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Concerta Side Effects

Cardiovascular EventsPeople with known heart problems should not take Concerta.

Psychiatric ReactionsMania, hallucinations and other psychiatric symptoms may occur in patients taking methylphenidate.

Physical DependenceConcerta is a Schedule II substance that can lead to physical and psychological dependence.

Concerta (methylphenidate hydrochloride) is a central nervous system stimulant used to treat children and adults with attention deficit-hyperactivity disorder (ADHD).

The drug contains the same active ingredient as Ritalin, another popular ADHD treatment, but Concerta only has to be taken once a day because it comes in an extended-release tablet.

The most common side effects of the medication include headache, abdominal pain, insomnia, decreased appetite, nervousness and dizziness. But the drug can also cause serious side effects that range from drug dependence to growth suppression to psychiatric problems.

Common Side Effects in Children vs. Adults

In clinical trials, upper abdominal pain was the most common side effect reported in both children and adolescents. About 6.2 percent of participants reported the symptom. Other common reactions in these age groups included vomiting, fever, insomnia, dizziness, coughs and common colds.

The most frequent side effects reported by adults in a clinical trial were:

Decreased appetite (25.3 percent)

Headache (22.2 percent)

Dry Mouth (14 percent)

Nausea (12.8 percent)

Anxiety (8.2 percent)

Dizziness (6.7 percent)

Weight loss (6.5 percent)

Irritability (5.8 percent)

Increased sweating (5.1 percent)

Elevated heart rate (4.8 percent)

Depressed mood (3.9 percent)

Nervousness and restlessness (3.1 percent)

Heart palpitations (3.1 percent)

Other side effects in adults that occurred less than 2 percent of the time included dizziness, blurred vision, constipation, vomiting, anorexia, muscle tightness, tingling sensations, aggression, depression, confusion, a lower sex drive, and grinding or clenching of the teeth.

Concerta 27mg

Concerta 18mg

Dependence and Withdrawal

The Drug Enforcement Administration classifies Concerta as a Schedule II controlled substance. This means it has a high potential for abuse and physical dependence. The drug’s packaging warns doctors to be cautious when prescribing it to patients with a history of alcoholism or drug addiction and dependence.

Drugs containing methylphenidate can cause an intense high similar to the effects of amphetamines when they’re crushed and snorted. Others may misuse prescription stimulants to improve academic performance or to suppress their appetite and promote weight loss.

That’s why it’s important to take Concerta only as directed. And if you’re a parent, keep close tabs on your child’s prescription. Teens, adolescents and college students have been known to share, sell or trade their pills to friends and others.

Did You Know?

Injecting Concerta into a vein may cause psychotic episodes, according to the drug’s label. People who abuse the drug or develop a dependence may develop severe depression during withdrawal.

A 2006 study by researchers at Harvard suggests the medication may be less prone to abuse than Ritalin because it produced less euphoric effects in 12 test subjects. The study also noted the pills are harder to crush, which makes them more resistant to abuse.

Cardiovascular Effects

Concerta may cause slight increases in heart rate and blood pressure. Blood pressure readings typically increase by two to four points and heart rate usually only increases by three to six beats per minute. But in certain people these changes may be more pronounced.

Vital Signs

The FDA says to monitor people who take ADHD medications for changes in their heart rate or blood pressure.

The drug’s warning label cautions people with underlying heart conditions not to take the drug. Stimulant medications have been linked to sudden death in children and adolescents with structural cardiac abnormalities or other serious heart problems. Adults taking stimulant drugs have also died suddenly or suffered strokes and heart attacks.

Despite the warning, the risk of experiencing a serious cardiac event while taking ADHD stimulants appears to be low.

In 2006, the FDA announced it had identified 17 reports of sudden deaths — including the deaths of 12 children — and 35 cases of heart problems or stroke in people taking amphetamines. Those case reports prompted the FDA to include stringent black box warnings on all stimulant medications.

But in 2011, the FDA issued an update about cardiovascular risks associated with ADHD medications. The agency based the update on a large study published in The New England Journal of Medicine. It found “no evidence of an increased risk of serious cardiovascular effects among children and young people” taking the drugs.

The study tracked more than 1.2 million children and young adults taking various ADHD medications, and it identified seven serious cardiac events among current users of the drug and 81 events in total.

Before a patient starts Concerta, it’s important to let a doctor know if the patient has pre-existing high blood pressure, heart failure, recent heart attack or abnormal heart rhythms arising from the lower chambers of the heart.

Patients who take a stimulant need immediate medical treatment if they develop symptoms such as chest pain along with physical effort, unexplained fainting or other signs of cardiac trouble.

Psychiatric Effects: Mania, Psychosis and Suicidal Behavior

Methylphenidate can cause an array of psychiatric side effects, particularly among people with pre-existing mental illness.

The drug may trigger episodes of mania in people with bipolar illness. Though rare, some patients may develop hallucinations, delusions and other symptoms of psychosis after taking therapeutic doses of the medication.

Clinical trial results have also noted aggressive behavior, a common symptom of ADHD. Let a doctor know if this behavior worsens during treatment.

Suicidal Thinking and Behavior

Anecdotal reports detail instances of suicidal thinking and suicide attempts among young people who take methylphenidate. In many of these cases, suicidal behavior ceased when the patient stopped taking the drug.

But other studies suggest treating young people with ADHD medications may actually lower a person’s suicide risk.

A 2017 case series study in the medical journal JAMA Psychiatry looked at more than 25,600 patients taking methylphenidate for ADHD.

The study found the risk of attempting suicide was six and a half times higher during the three months prior to starting the medication, and the risk reduced slightly but remained elevated during the first 90 days of treatment. With continued treatment, however, the risk of suicide attempts dropped 72 percent.

Other Serious Side Effects

Other serious side effects reported with Concerta use range from visual disturbances to vascular problems to movement disorders. The drug is contraindicated in people with glaucoma, motor tics, and anxiety and agitation.

Stimulant drugs may lower the threshold at which a patient with a seizure disorder develops convulsions. The drug’s label instructs patients to stop treatment if seizures occur.

Don’t take the medication if you’re on an antidepressant that’s an MAO inhibitor because it may cause a dangerous rise in blood pressure, according to the drug’s label.

Raynaud’s Phenomenon

Some patients who took Concerta developed Raynaud’s phenomenon. The painful disorder most commonly affects the fingers, but about 40 percent of people with the condition will also experience its effects in their toes.

Raynaud’s phenomenon most commonly affects fingers.

With Raynaud’s phenomenon, cold air triggers spasms in the small blood vessels of the extremities. The spasms temporarily cut off blood flow.

The skin may first turn white before it turns blue for a short time. As the blood flow returns, the affected areas may turn red.

Patients may experience throbbing, tingling, burning or numbness. In rare cases, tissue deprived of blood flow for long periods of time may develop gangrene.

Involuntary Movements

In one long-term study, 9 percent of 432 children developed involuntary movements or vocalizations known as “tics” after two or more years on Concerta. In a second study that tracked 682 children for an average of seven months, less than 1 percent developed new tics.

If tics are an issue, ask your doctor what other medications are available. According to Baylor College of medicine, Strattera (atomoxetine), a non-stimulant medication, tends to be “well tolerated by children with tics.”

Stunted Growth

Clinical studies have revealed a temporary slowing of growth in children who consistently take daily doses of methylphenidate.

An October 2011 study published in Prescrire International looked at more than 500 children on methylphenidate and found the children grew 2 cm less in height and gained about six fewer pounds over the course of three years. Other studies have found a 1 cm to 1.5 cm slowing of growth per year, and most kids caught up on their growth in the two years after they stopped the drug.

According to the drug’s label, doctors should track growth in children who take Concerta or other stimulants, and they should consider stopping therapy in patients who don’t grow or gain weight as they should.

Prolonged Erections

Patients have reported prolonged and painful erections with methylphenidate-containing products. Known as priapism, the condition is not the result of sexual stimulation. Instead, it happens when blood becomes trapped in the penis.

The condition doesn’t generally develop immediately. It occurs after “some time on the drug” or when dosage is increased. It may also occur when a person stops using the drug or takes a brief break from it.

In 2013, the FDA warned priapism can occur with methylphenidate ADHD medications, and it approved label changes to reflect the rare risk. The agency reviewed adverse event report submitted between 1997 and 2012 and found 15 patients who developed the condition from a methylphenidate drug.

Two of the patients needed surgery. Four of the cases occurred when patients stopped taking the drug.

Concerta users who experience unusually frequent or painful erections should seek immediate medical treatment, according to the FDA.

Please seek the advice of a medical professional before making health care decisions.

Amy Keller is a registered nurse and award-winning journalist with 22 years of experience writing about politics, business, health and other topics. At Drugwatch, she draws on her clinical experience and investigative reporting skills to write about consumers’ health concerns such as the safety of online pharmacies. She also provides informed analysis on complex health issues. Some of her qualifications include:

U.S. Food and Drug Administration. (2011, November 1). FDA Drug Safety Communication: Safety Review Update of Medications used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in children and young adults. Retrieved from https://www.fda.gov/Drugs/DrugSafety/ucm277770.htm

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